BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 54F

    MDR report key: 19222868 · Received May 1, 2024

    Report

    Report Number
    0001825034-2024-01116
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    April 26, 2023
    Report Date
    May 1, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304524231
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT #: 192113 / ECHO POR FMRL LAT NC 13X145MM/ LOT #: 213200 CAT #: 00625006535 / BONE SCR 6.5X35 SELF-TAP / LOT #: 65459622 CAT #: 20103606 / G7 LONGEVITY NEUTRAL 36MM F / LOT #: 65502075 CAT #: 650-0661 / DELTA CERAMIC FEM HD 36/0MM / LOT #: 3128005. BURSITIS IS THE INFLAMMATION OR IRRITATION OF THE BURSAE (THE FLUID FILLED SAC THAT CUSHIONS THE JOINT) AND IS TYPICALLY CAUSED BY REPETITIVE MOTION, OVERUSE, AND PRESSURE TO THE BURSAE. BURSITIS IS A VERY COMMON CONDITION THAT CAN IMPACT ANY OF THE JOINTS AND CAN LAST FOR A SHORT DURATION OR YEARS. SYMPTOMS THE PATIENT CAN EXPERIENCE INCLUDE PAIN, TENDERNESS, SWELLING, STIFFNESS, DECREASE IN MOVEMENT, AND/OR REDNESS AT OR AROUND THE JOINT THAT IS INVOLVED. CONSERVATIVE TREATMENT CONSISTS OF OVER THE COUNTER (OTC) MEDICATIONS PAIN RELIEVERS AND ANTI-INFLAMMATORIES, REST, ICE, ELEVATION, AND APPLYING PRESSURE WRAPS. IF CONSERVATIVE TREATMENTS FAIL, PHYSICAL THERAPY, ASPIRATION, ARTHROSCOPY, OR STEROID INJECTIONS MAY BE NECESSARY. THE COMPLAINT INDICATES THAT POSTOP BURSITIS DEVELOPED AND REQUIRED MEDICAL INTERVENTION FOR TREATMENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT RECEIVED A CORTISONE INJECTION APPROXIMATELY THREE MONTHS POST IMPLANTATION FOR LATERAL HIP PAIN AND TROCHANTERIC BURSITIS. THEN AGAIN ONE YEAR POST IMPLANTATION DUE TO MILD PAIN, MODERATE DIFFICULTIES WITH ADL¿S, SNAPPING SENSATION AND DIFFICULTY SLEEPING. THE PATIENT WAS PRESCRIBED A CORTICOSTEROID INJECTION IN THE RIGHT TROCHANTERIC BURSA, VOLTAREN GEL AND A PRESCRIPTION FOR PT, POSSIBLY DRY NEEDLING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154448 G7 PPS LTD ACET SHELL 54F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. NI R7301744A 00880304524231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE